Z-1775-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2022
- Initiation Date
- August 19, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 US
Product Description
Puritan Bennett 560 Ventilator, PB560, CFN 4096600
Reason for Recall
Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
Distribution Pattern
Domestic distribution to one customer in Washington, D.C. Foreign distribution worldwide.
Code Information
UDI-DI: 10884521196377 U.S. Serial Numbers: 40966N7229 40966N7231 40966N7334 40966N7335 40966N7340